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FDA 510(k)

BR-50-J DISPOSABLE ECG ELECTRODE

K-Number: K921579 · 1992-05-26

ApplicantMedicotest, Inc.
Decision Date1992-05-26
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BR-50-J DISPOSABLE ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Medicotest, Inc.. It received FDA 510(k) clearance on 1992-05-26 under 510(k) number K921579. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BR-50-J DISPOSABLE ECG ELECTRODE?

BR-50-J DISPOSABLE ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1992-05-26. The listed applicant is Medicotest, Inc.. The 510(k) number is K921579.

When did BR-50-J DISPOSABLE ECG ELECTRODE receive FDA 510(k) clearance?

BR-50-J DISPOSABLE ECG ELECTRODE received FDA 510(k) clearance on 1992-05-26, under 510(k) number K921579.

Who is the listed applicant for BR-50-J DISPOSABLE ECG ELECTRODE?

The FDA 510(k) record lists Medicotest, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BR-50-J DISPOSABLE ECG ELECTRODE?

The FDA product code for BR-50-J DISPOSABLE ECG ELECTRODE is DRX.

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Other records listing Medicotest, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983597NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODESK970639NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-KK961643MEDICOTEST ECG ELECTRODESK952176DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-KK941568K-10-VS, DA-05-VS, RECORDING ELECTRODESK931430CUTANEOUS ELECTRODE

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Related Devices (Code: DRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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